# K213786: CiRX Single use electrosurgical pencil with non-coated and coated electrode

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Shun YE Medical Company, Ltd.
- Decided: Jun 27, 2022 after 203 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K965054 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192542: Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde, Modern Medical Equipment Manufacturing, Ltd. (2020) Summary page 6.

## Most influential descendants
- K232460: Disposable electrosurgical pencil (MD1000) (2023), 0 descendants of its own

## Indications for use
The device is to be used in combination with a standard electrosurgical generator to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.

Source page: https://510kreport.com/device/K213786
Methodology: https://510kreport.com/methodology